- Role: Clinical Project Manager
- Location: UK – home-based
- Company: Tech Driven CRO
- Salary – Very competitive will discuss on application
We are looking for a Clinical Project Manager to join one of our technology driven CRO who are bringing innovation to the market. Their ground-breaking technology separates them from competitors and allows them to provide decentralized clinical trials to some of the top pharma giants.
- Develop study plan outlining planning, execution, and closeout milestones.
- Develop a study management plan in conjunction and sponsor representative(s) outlining target KPIs, risk assessment, and contingency planning.
- Lead multidisciplinary Study Management Team.
- End-to-end management of clinical studies to ensure appropriate resourcing and timely and high-quality delivery by all functional areas. Ability to identify and organize resources and services needed to accomplish tasks, set objectives, plan for contingencies, and managing time effect.
- Assist in screening, selection, and management vendors in accordance with contractual timelines, sponsor specifications, quality, budget, and GCP.
- Develop and monitor study metrics to continuously assess study progress.
- Act as the primary point of contact between Science 37 and sponsor project team.
- In collaboration with the study management team, and Marketing, develop a robust recruitment and retention data-driven strategic plan including risk assessment and contingency planning, at the start of the study and monitored throughout its duration and to close-down.
- Identify critical project success factors for tracking, analysis and reporting including impact and probability of project risks.
- Monitor and track study status, timelines, and budget expenditures; identifies opportunities and recommend Implementation plan for efficiency measures.
- Accountable for overall study budget, ensuring that all invoices are paid, issues are addressed, and revenues are booked in timely manner.
- Ensures timely data entry, query resolution and prompt resolution of data issues.
- Coordinate assignment of needed resources for study conduct and completion with functional area leaders; ensure appropriate staffing to accomplish project goals within budget.
- Identify out-of-scope work and reports the scope change process to leadership.
- Responsible for review of study budget, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members.
- Manage clinical research coordinators and their activities on each study.
- Ensure that study activities (personal and those of the Clinical Research Coordinators) are properly tracked and entered into the company’s time tracking/project management/resource planning software tool in a timely manner.
- Ability to analyze data and information to derive conclusions and drive critical decision-making
- Accountable for development, oversight and delivery of team training for specific projects.
- Applies expertise in day-to-day clinical operations activities, collaborate with internal and external cross-functional team members to develop study documents and manuals, including protocols, ICFs, manuals, presentation decks, risk plans, etc.
- Determines needed project processes and trains study teams; maintains study team knowledge and application of project processes.
- Establish and communicate team performance expectations and guidelines.
- Mentor and assist in coaching/training Clinical Research Coordinators.
- Conduct performance reviews, calibration sessions and feedback discussions for clinical research coordinators. Perform competency assessments across his/her team and implements and monitors development plans with direct reports.
- Manage performance of external service providers as required.
- Provide performance evaluation input for Science 37 project team members and service providers.
- Participate in development and review of departmental Standard Operating Procedures (SOPs), guidelines, intradepartmental procedures, and other continuous process improvements programs, as assigned.
- Bachelor’s degree required. Advanced degree or equivalent clinical research experience preferred.
- 8+ years of in-depth knowledge of pharmaceutical/biotech-sponsored clinical study management experience or equivalent applicable experience.
- Medical and scientific knowledge preferred
By clicking “apply” you will be sending your CV to Alex Smith at Barrington James. Alex is a Specialist Clinical Operations/Development Recruiter with a strong background in recruitment and the life science field. Alex will discuss the opportunity in detail with you, facilitate your application and will manage the process acting as a link between the company and yourself. He will assist in all elements of the process, facilitate the offer process, keep in contact throughout your notice period and even catch up with you during your first week in your new role.
This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply without delay as it is likely that recruitment will close prematurely. Please direct all questions (if necessary) to Alex Smith at asmith@barringtonjames alongside a copy of your CV.
We are looking to put a shortlist together for this client, to highlight your interest please send your CV or an email to Alex Smith